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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

 

Contact:
Cardinal Health
800-292-9332

 

FOR IMMEDIATE RELEASE -- Elgin, IL -- May 2, 2008 Hydrox Labs, Elgin, IL has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash.  As a result of this recall, Cardinal Health is initiating a voluntary recall of the same alcohol-free mouthwash. The FDA has been apprised of the action.  The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.

Product was distributed to hospitals, medical centers, and long term care facilities nationwide.

B. cepacia poses little medical risk to healthy people.  However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia.  B. cepacia is a known cause of infections in hospitalized patients.  B. cepacia bacteria are often resistant to common antibiotics.  The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF.

The recall includes the following products:

Description

Reorder Number

Alcohol-Free Mouthwash, Cardinal Health, 4 oz.AG-210

Product lot number 26228 is affected.  Affected product can be identified by checking the lot code stamped on the Cardinal Health label.  The Lot number is located on the side of the bottle. 

The mouthwash may also be found in certain Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Cardinal Health from your healthcare provider, please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number.

Customers who have Cardinal Health labeled alcohol free mouthwash which is being recalled should stop using the product and contact Cardinal Health for instructions.

Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

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